Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | SILIKON 1000 |
Generic Name | Fluid, intraocular |
Regulation Number | 886.4275 |
Applicant | ALCON 6201 SOUTH FREEWAY MAIL DROP R7-14 FORT WORTH, TX 76134-2099 |
PMA Number | P950008 |
Supplement Number | S007 |
Date Received | 05/04/2009 |
Decision Date | 10/30/2009 |
Product Code |
LWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS OF SPECIFICATION RANGES FOR VISCOSITY AND MOLECULAR WEIGHT. THE CURRENT SPECIFICATIONS FOR VISCOSITY AND MOLECULAR WEIGHT ARE 900 ¿ 1,250 CS AND 32,850 ¿ 47,000 DALTONS, RESPECTIVELY. THE PROPOSED REGULATORY ACCEPTANCE SPECIFICATIONS FOR VISCOSITY AND MOLECULAR WEIGHT ARE 980 ¿ 1,350 CS AND 31,000 ¿ 44,500 DALTONS, RESPECTIVELY. |
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